Abstract | BACKGROUND AND PURPOSE: METHODS: Two hundred sixty patients with acute ischemic stroke were randomized in a placebo-controlled, prospective, open-label treatment, blinded outcome reading multicenter trial. Subjects with a National Institutes of Health Stroke Scale between 4 and 18 received intravenously either tirofiban or placebo within 3 to 22 hours after symptom onset for 48 hours. The primary end point was the rate of cerebral bleeding as measured in follow-up CT scans 2 to 7 days after inclusion. The secondary end point was clinical efficacy within 1 week (National Institutes of Health Stroke Scale, modified Rankin Scale) and after 5 months (Barthel Index, modified Rankin Scale). RESULTS: The rate of cerebral hemorrhagic transformation (I/II) and parenchymal hemorrhage (I/II) did not differ between both groups ( tirofiban 36 of 120; placebo 33 of 124: OR, 1.18; 95% CI, 0.66 to 2.06). Mortality after 5 months was significantly lower in patients treated with tirofiban (3 of 130 [2.3%] versus 11 of 126 [8.7%]; OR, 4.05; 95% CI, 1.1 to 14.9). No difference in neurological/functional outcome was found after 1 week and after 5 months. CONCLUSIONS: We conclude that tirofiban might be safe in acute moderate ischemic stroke even when administered within a large time window after symptom onset and might save lives in the late outcome. Clinical Trial Registration- URL: www.strokecenter.org/trials/. Trial name: SaTIS. Enrollment began before July 1, 2005.
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Authors | Mario Siebler, Michael G Hennerici, Dietmar Schneider, Gerhard M von Reutern, Rüdiger J Seitz, Joachim Röther, Otto W Witte, Gerhard Hamann, Ulrich Junghans, Arno Villringer, Jochen B Fiebach |
Journal | Stroke
(Stroke)
Vol. 42
Issue 9
Pg. 2388-92
(Sep 2011)
ISSN: 1524-4628 [Electronic] United States |
PMID | 21852609
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Platelet Aggregation Inhibitors
- Tyrosine
- Tirofiban
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Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Brain Ischemia
(diagnostic imaging, drug therapy, mortality)
- Female
- Humans
- Intracranial Hemorrhages
(diagnostic imaging, drug therapy, mortality)
- Male
- Middle Aged
- Platelet Aggregation Inhibitors
(administration & dosage, adverse effects)
- Prospective Studies
- Radiography
- Stroke
(diagnostic imaging, drug therapy, mortality)
- Time Factors
- Tirofiban
- Tyrosine
(administration & dosage, adverse effects, analogs & derivatives)
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